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REducing Anxiety in CHildren Undergoing Procedures (REACH-UP!)

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ClinicalTrials.gov Identifier: NCT03054077
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : October 10, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition: Ambulatory Surgery
Intervention: Other: iPad with downloaded games

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control or Group 1 This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
Intervention Group or Group 2

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit


Participant Flow:   Overall Study
    Control or Group 1   Intervention Group or Group 2
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control or Group 1 This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
Intervention Group or Group 2

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

iPad with downloaded games: iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit

Total Total of all reporting groups

Baseline Measures
   Control or Group 1   Intervention Group or Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      12 100.0%      12 100.0%      24 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  33.3%      3  25.0%      7  29.2% 
Male      8  66.7%      9  75.0%      17  70.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      12 100.0%      12 100.0%      24 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   8.3%      1   4.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7  58.3%      4  33.3%      11  45.8% 
White      4  33.3%      7  58.3%      11  45.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   8.3%      0   0.0%      1   4.2% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2   [ Time Frame: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Debra Shockey
Organization: Virginia Commonwealth University
phone: 804-828-3744
e-mail: dpshockey@vcu.edu


Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03054077     History of Changes
Other Study ID Numbers: HM200008056
First Submitted: January 31, 2017
First Posted: February 15, 2017
Results First Submitted: July 7, 2017
Results First Posted: October 10, 2017
Last Update Posted: October 10, 2017